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Vaccination In Peripheral Stem Cell Transplant Setting For Multiple Myeloma: The Use Of Autologous Tumor Cells/An Allo PSCT


Phase 1/Phase 2
18 Years
70 Years
Open (Enrolling)
Both
Multiple Myeloma and Plasma Cell Neoplasm

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Trial Information

Vaccination In Peripheral Stem Cell Transplant Setting For Multiple Myeloma: The Use Of Autologous Tumor Cells/An Allo PSCT


OBJECTIVES:

- Determine the efficacy of induction chemotherapy followed by autologous tumor cell
vaccine and autologous peripheral blood stem cell transplantation in patients with
multiple myeloma.

- Determine the safety of this regimen in these patients.

OUTLINE: Autologous tumor cells are harvested. The vaccine is prepared in vitro by mixing
autologous tumor cells with a bystander cell expressing sargramostim (GM-CSF). Patients
receive induction chemotherapy followed by autologous tumor cell vaccination (ATCV) once.
Patients then undergo autologous peripheral blood stem cell transplantation. At 6 weeks
after transplantation, patients receive additional ATCVs every 3 weeks for a total of 8
vaccinations.

PROJECTED ACCRUAL: A total of 25 patients will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Newly diagnosed multiple myeloma

- More than 30% bone marrow involvement

- Eligible for autologous peripheral blood stem cell transplantation

PATIENT CHARACTERISTICS:

Age:

- 18 to 70

Performance status:

- ECOG 0-2

Life expectancy:

- Not specified

Hematopoietic:

- Absolute neutrophil count greater than 500/mm^3

- Platelet count greater than 30,000/mm^3

Hepatic:

- Bilirubin less than 3 times normal

- AST/ALT less than 3 times normal

Renal:

- Not specified

Other:

- Not pregnant

- HIV negative

- No prior or active autoimmune disease

- No other prior malignancy within the past 5 years

- No major active medical or psychosocial problems

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- See Disease Characteristics

Chemotherapy:

- No more than 1 prior course of chemotherapy

Endocrine therapy:

- Not specified

Radiotherapy:

- Concurrent local radiotherapy allowed

Surgery:

- Not specified

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Ivan Borrello, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Sidney Kimmel Comprehensive Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000068953

NCT ID:

NCT00024466

Start Date:

March 2001

Completion Date:

Related Keywords:

  • Multiple Myeloma and Plasma Cell Neoplasm
  • stage I multiple myeloma
  • stage II multiple myeloma
  • stage III multiple myeloma
  • Neoplasms
  • Multiple Myeloma
  • Neoplasms, Plasma Cell
  • Plasmacytoma

Name

Location

Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsBaltimore, Maryland  21231-2410